1. DESCRIPTION OF THE SUBJECT OF THE ORDER:
1. Screening kits for newborn testing for:
- Pompe disease – measurement of alpha-glucosidase (GAA) activity;
- Fabry disease – measurement of alpha-galactosidase A (GLA) enzyme activity;
- Gaucher disease – measurement of glucocerebrosidase (GBA) enzyme activity;
- Mucopolysaccharidosis type I (MPSI)
using tandem mass spectrometry (MS/MS) for a total of 360,000 tests on microplates, each containing 96 wells.
2. In selecting the most advantageous offer, the Purchaser reserves the right to reduce the purchase of reagents, but not by more than 20% of the above-mentioned subject of the order, in the event of exceeding the amount allocated for the realization of the order or the occurrence of objective and justified circumstances, particularly a decrease in the expected number of births and tests.
3. The Contractor is required to deliver kits packaged for 2400 tests or less (1920, 960).
4. In accordance with Article 257 of the Public Procurement Law, the Purchaser reserves the right to annul the public procurement procedure if the funds intended for financing the entirety or part of the order have not been granted.
5. The order must be executed in accordance with the requirements specified in this SWZ, the Draft Agreement terms, and other tender documentation.

LOT-0001
ACQUISITION OF NEWBORN SCREENING KITS (...) (MS/MS)
PURCHASE OF NEWBORN SCREENING KITS FOR LYSOSOMAL STORAGE DISORDERS (PANEL OF 4 DISEASES: POMPE DISEASE, FABRY DISEASE, GAUCHER DISEASE AND MUCOPOLYSACCHARIDOSIS TYPE I) USING TANDEM MASS SPECTROMETRY (MS/MS).
DESCRIPTION OF THE SUBJECT OF THE ORDER:
1. Screening kits for newborn testing for:
- Pompe disease – measurement of alpha-glucosidase (GAA) activity;
- Fabry disease – measurement of alpha-galactosidase A (GLA) enzyme activity;
- Gaucher disease – measurement of glucocerebrosidase (GBA) enzyme activity;
- Mucopolysaccharidosis type I (MPSI)
using tandem mass spectrometry (MS/MS) for a total of 360,000 tests on microplates, each containing 96 wells.
2. In selecting the most advantageous offer, the Purchaser reserves the right to reduce the purchase of reagents, but not by more than 20% of the above-mentioned subject of the order, in the event of exceeding the amount allocated for the realization of the order or the occurrence of objective and justified circumstances, particularly a decrease in the expected number of births and tests.
3. The Contractor is required to deliver kits packaged for 2400 tests or less (1920, 960).
4. In accordance with Article 257 of the Public Procurement Law, the Purchaser reserves the right to annul the public procurement procedure if the funds intended for financing the entirety or part of the order have not been granted.
5. The order must be executed in accordance with the requirements specified in this SWZ, the Draft Agreement terms, and other tender documentation.
SUBJECTIVE EVIDENCE:
1. Based on Articles 105 and 106 of the Public Procurement Law, in order to confirm the compliance of the offered supplies with the requirements, features, or criteria defined in the description of the subject of the order or evaluation criteria or requirements related to the execution of the order, the Purchaser requires Contractors to present the following documents:
1.1. Declaration of compliance issued by the manufacturer of the product,
1.2. CE-IVD certificate / certificates from notified bodies that participated in the product conformity assessment process - if applicable
1.3. Declaration of subjection / non-subjection to the obligation to notify data about the product to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products based on Article 58(1) or Article 58(2) of the Act of May 20, 2010 on medical devices (Journal of Laws of 2021, item 1565, as amended), in connection with Article 138 of the Act of April 7, 2022 on medical devices (Journal of Laws of 2022, item 974, as amended) and alternatively
a) if the offeror is a manufacturer of the product based in the territory of the Republic of Poland, submit a declaration of compliance with the obligation to notify based on Article 58(1) or Article 58(2) of the Act of May 20, 2010 on medical devices (Journal of Laws of 2021, item 1565, as amended), in connection with Article 138 of the Act of April 7, 2022 on medical devices (Journal of Laws of 2022, item 974, as amended);
b) if the offeror is an importer or distributor who introduces the product to the territory of the Republic of Poland for the first time, submit a declaration of compliance with the obligation to notify based on Article 58(3) of the Act together with a declaration on whether such notification has already been made or that such notification will be made in accordance with the law, i.e., within 7 days from the introduction of the first product into the territory of the Republic of Poland;
c) if the offeror is another distributor or manufacturer of the product based outside the territory of the Republic of Poland, submit a declaration stating the reasons for the lack of this obligation along with the procurement source of the offered product - if applicable;
1.4. Contractor's declaration regarding the blotting paper used for control testing.
1.5. Contractor's declaration that the kit is compatible and validated on SCIEX devices.
1.6. A full instruction for the offered test, which includes the following information:
a) characteristics and intended use of the test;
b) components of the kit (reagents, materials);
c) controls – applied blotting paper, blood, hematocrit;
d) materials necessary for conducting the test not included in the kit;
e) description of the testing procedure;
f) characteristics of the test - sensitivity, accuracy, intra-test and inter-test variability;
or in the case of point 1.6. subpoint c, the Purchaser agrees to the absence of information on the applied blotting paper in the test instructions if this information is provided as a declaration of the contractor.
2. The documents mentioned above are submitted in the form of an original electronic document or a copy certified as true to the original by the Contractor using a qualified electronic signature.
3. In accordance with Article 107(1) of the Public Procurement Law. The Contractor is obliged to submit the above-mentioned pieces of evidence with the offer and must exercise utmost diligence to ensure that these documents are complete and contain all necessary information enabling the Purchaser to verify them for correctness.
4. The documents mentioned must have a validity period covering the entire duration of the order.
5. The documents mentioned above are submitted in a manner provided for in the regulations issued based on Article 70 of the Public Procurement Law, i.e., in the Regulation of the Prime Minister of December 30, 2020, concerning the preparation and submission of information and technical requirements for electronic documents and means of electronic communication in public procurement or competition procedures.
6. In accordance with Article 107(2) of the Public Procurement Law, the Purchaser allows for one-time supplementation of the objective evidence mentioned in points 1.1., 1.2., 1.3., 1.5., 1.6. within the timeframe set by the Purchaser.
7. In accordance with Article 107(3) of the Public Procurement Law, the Purchaser does not foresee the possibility of supplementing the objective evidence referred to in point 1.4, as this objective evidence will serve to confirm compliance with the features or criteria specified in the description of the criteria.
8. Documents prepared in a foreign language are submitted together with a translation into Polish.